FDA 510(k)

NextDent Ortho Flex

K-Number: K221022 · 2022-10-21

Decision Date2022-10-21

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

NextDent Ortho Flex is the device name listed in this FDA 510(k) record. The listed applicant is Vertex-Dental B.V.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K221022. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NextDent Ortho Flex?

NextDent Ortho Flex is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Vertex-Dental B.V.. The 510(k) number is K221022.

When did NextDent Ortho Flex receive FDA 510(k) clearance?

NextDent Ortho Flex received FDA 510(k) clearance on 2022-10-21, under 510(k) number K221022.

Who is the listed applicant for NextDent Ortho Flex?

The FDA 510(k) record lists Vertex-Dental B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NextDent Ortho Flex?

The FDA product code for NextDent Ortho Flex is MQC.

Other records listing Vertex-Dental B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241071NextDent Jet Denture Base; NextDent Jet Denture Teeth K231388NextDent Base K191497NextDent Denture 3D+K162572NextDent Denture, E-Denture

Related Devices (Code: MQC)

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemvia K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation K243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.